The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Embrace Petite Breast Pump.
| Device ID | K061013 |
| 510k Number | K061013 |
| Device Name: | PLAYTEX EMBRACE PETITE BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Karin E Jordan |
| Correspondent | Karin E Jordan PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-08-15 |
| Summary: | summary |